Clarimax

COMPOSITION :

Each 5ml (teaspoonful) of reconstituted suspension contains :

Clarithromycin USP 125mg, 250mg.

Each f/c tablet contains :

Clarithromycin USP 250mg , 500mg.

DESCRIPTION :

Clarimax (Clarithromycin) is a new macrolide antibiotic. It exerts its antibacterial activity by linking to the 50S

ribosomal subunit and inhibit protein synthesis of susceptible bacteria. Clarithromycin is highly potent against a wide

variety of aerobic, anaerobic, gram positive and gram negative organisms. It is active against the following organisms

in vitro: Streptococcus(agalactiae, pyogenes, viridans, pneumoniae), Haemophilus (influenzae, parainfluenzae),

Neisseria gonorrheae, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Helicobacter

pylori, Campylobacter jejuni, Chlamydia trachomatis, Moraxilla (Branhamella) catarrhalis, Bordetella pertussis,

Staphylococcus aureus, Propionibacterium acnes, Mycobacterium(avium, leprae, kansasii, chelonae, fortuitum,

intracellulare). Clarithromycin is rapidly absorbed from the gastro-intestinal tract following oral administration. The

extent of absorption is relatively unaffected by the presence of food. After absorption, clarithromycin rapid diffuses in

the majority of tissues excluding CNS, without significant differences in concentration. It is metabolized in the liver.

The principal metabolite of Clarithromycin is a microbiologically active metabolite, 14-hydroxy-clarithromycin. 80% of

Clarithromycin bound to plasma proteins at therapeutic levels. Clarithromycin & its metabolites are excreted in urine

& faeces.

INDICATIONS :

Clarimax is indicated in the treatment of :

-Infections of nasopharyngeal tract (tonsillitis, pharyngitis), paranasal sinuses and otitis media.

-Infections of lower respiratory tract (bronchitis, bacterial pneumonia and atypical pneumonia).

-Skin infections (impetigo, erysipelas, folliculitis, furunculosis and septic wounds).

-Eradication of H.pylori in patients with proven duodenal ulcer.

DOSAGE & ADMINISTRATION :

Clarimax may be given without regard to meals as follow :-

•Adults and Children older than 12 years : The usual dose is 250mg every 12 hours for 7 days, can be increased

to 500mg every 12 hours in severe infections for up to 14 days.

•Children younger than 12 years : Using Clarimax suspension as follow :

Children over 6 months the recommended daily dose is 15mg / kg /

day in two divided doses. The dose can be increased according to the

severity of illness and physician's opinion.

•For eradication of H. pylori for adults and eldery :

- Dual therapy : Clarimax tablets 500mg three times daily for 14 days, and should be administered with oral

Omeprazole 40mg once daily.

- Triple therapy : Clarimax tablets 500mg twice daily should be given with Amoxicillin 1000mg twice daily and

Omeprazole 20mg daily for 10 days.

•In patients with renal impairment (Creatinine clearance less than 30 ml / min) the dosage should be reduced by

one-half and should not be continued beyond 14 days.

RESTRICTIONS ON USE :

Contraindications

-Patients with known hypersensitivity to macrolide antibiotic drugs.

-Patients with severe liver insufficiency.

-Concomitant administration of Clarithromycin and any of the following drug is contraindicated (ergot derivatives,

cisapride, pimozide and terfenadine).

Use in pregnancy and lactation

Clarithromycin should not be used during pregnancy and lactation unless the benefit is considered out weight the risk.

Child weight (kg)

5 - 10

11- 20

21- 30

62.5

125

187.5

Twice daily (mg)

Precautions

-Caution should be exercised in administering Clarithromycin to patients with impaired hepatic or renal function and

to elderly patients.

-Prolonged or repeated use of Clarithromycin may result in an overgrowth of non susceptible bacteria or fungi, if

superinfection occurs, Clarithromycin should be discontinued and appropriate therapy instituted.

-H. pylori may develop resistance to Clarithromycin in small number of patients.

DRUG INTERACTIONS :

-Using of Clarithromycin concurrently with drugs metabolized by the cytochrome P450 system (eg. warfarin, ergot

alkaloids, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin and tacrolimus) may be

associated with elevation in serum levels of these drugs.

-The use of clarithromycin with warfarin lead to potentiation of the effects of warfarin, and prothrombin time should

be frequently monitored.

-Concomitant administration of Clarithromycin with theophylline lead to increased serum theophyllin levels and

potential theophylline toxicity.

-Clarithromycin may potentiate the effects of digoxin, monitoring of serum digoxin should be considered.

-Clarithromycin may potentiate the effects of carbamazepine.

-Although plasma concentration of Clarithromycin and Omeprazole, may be increased when they are administered

concurrently, no adjustment to the dosage is necessary.

-Although plasma concentration of Clarithromycin may be increased when co-administered with Maalox or

ranitidine, no adjustment to the dosage is necessary.

-Oral administration of Clarithromycin tablet and zidovudine to HIV-infected adults may result in decreased steady

state zidovudine levels.

ADVERSE EFFECTS :

Clarithromycin is generally well tolerated and the side effects include :

-Nausea, dyspepsia, diarrhoea, vomiting, abdominal pain and paraesthesia, stomatitis, glossitis, oral monilia and

tongue discolouration have been reported.

-Other side effects include headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin

eruptions and angioedema to anaphylaxis and rarely Stevens Johnson syndrome.

-Alteration of the sense of smell usually conjunction with taste perversion.

-Tooth discoloration which is usually reversible with professional dental cleaning.

-Transient central nervous system side effects including dizziness, anxiety, insomnia, bad dreams, tinnitus,

confusion, disorientation, hallucination, psychosis and depersonalization.There have been reports of hearing loss

with clarithromycin which is usually reversible upon withdrawal of therapy.

-Rarely side effects include: Pseudomembranous colitis, hypoglycaemia, some of which occur in patients use

hypoglycaemic agents or insulin, leucopenia and thrombocytopenia. Hepatic dysfunction has been reported (which

is usually reversible)

STORAGE INSTRUCTIONS :

Dry Suspension : Store below 30°C, in a dry place.

Reconstituted Suspension : Store at room temperature for 14 days.

Tablets : Store below 30°C, in a dry place. Protect from light

PRESENTATIONS :

Clarimax 125 Powder for oral suspension: Bottle of 60ml or 100ml.

Clarimax 250 Powder for oral suspension: Bottle of 60ml or 100ml.

Clarimax 250 Tablets : Pack of 14 Tablets and hospital packs of different sizes.

Clarimax 500 Tablets : Pack of 14 Tablets and hospital packs of different sizes.

INSTRUCTIONS TO THE PATIENT

- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

- The doctor and the pharmacist are experts in medicine, its benefits and risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

Council of Arab Health Ministers

Mfd. By Union of Arab Pharmacists

P.O. Box : 4265 Sana’a /Yemen.

012-06-068 9/16